Combination syringe and vial mixing container



July 11, 1967 M. J. VISSER 3,330,281

COMBINATION SYRINGE AND VIAL MIXING CONTAINER Filed Aug. 21, 1964INVENTOR MELV/N J. V/SSER f/gz/re 1 BY W ATTORNEY United States Patent3,330,281 COMBINATION SYRINGE AND VIAL MIXING CONTAINER Melvin J.Visser, Portage, Mich., assignor to The Upjohn Company, Kalamazoo,Mich., a corporation of Delaware Filed Aug. 21, 1964, Ser. No. 391,219 3Claims. (Cl. 128-272) This invention relates to containers and, moreparticularly, to compartmented containers for separate maintenance ofmaterials prior to their use in combination.

Frequently it is desired to package in a single unit dry solids and areconstituting diluent or separately maintained liquids for mixing priorto use, as in the separate storage of sterile components of a mixture tobe injected into the human or animal body. Much attention has beenaccorded the development of such packages for the pharmaceuticalindustry in recent years. Various combinations of multiple-compartmentedinjection units have in fact been developed, but results thus far haveproved unsatisfactory for one or more of a variety of reasons which thecontainers of this invention are designed to overcome.

The device of this invention is remarkably simple in construction andeconomical to fabricate and fill. More important, however, is theprovision of a unit embodying components with which the physician isalready familiar. Where reconstitution or mixing of ingredients isnecessary prior to use, he is thus enabled to respond in emergencieswithout time-consuming reflection on mechanics of operation. In thisrespect the device hereof, with unique coaction between its basicelements, is a departure from compartmented injection devices of theart, which demonstrate remarkable ingenuity but too often involve costlyor complicated features that detract from their practical usefulness.

The device of this invention comprises essentially means defining amixing chamber for containing a first sterile ingredient for injectionto which is affixed means defining a storage chamber for containing asecond sterile fluid ingredient for injection. A penetrable plug sealsthe open, upper end of the mixing chamber. Communication between themixing and storage chambers is provided by a cannula mounted on themeans defining the storage chamber and extending through the penetrableplug. A pressure-expellable cap closes the lower, extended end of thecannula. The storage chamber carries a plunger with piston slidabletherein, whereby downward movement of the plunger and piston developspressure to expel the cap, causing the fluid ingredient of the storagechamber to enter the mixing chamber.

In its preferred embodiment the device of this invention comprises amixing vial containing a first sterile ingredient for injection atop ofwhich is positioned a syringe containing a second sterile fluidingredient, such as a diluent, for injection. The cannula of the syringeextends into the vial through a penetrable plug which both seals theneck of the vial and affords rigidity in the connection between thesyringe and the vial of the mounted assembly. A sealing pop-01f cap isfrictionally engaged over the extended end of the cannula inside thevial, the cap being expelled from the cannula on the downward movementof the plunger of the syringe, causing the fluid ingredient in thesyringe to mix with the first sterile ingredient in the vial. The entireunit is then inverted, the syringe withdrawn to a low point in theinverted vial and the mixed ingredients drawn into the syringe in theusual manner. The syringe is then withdrawn from the vial and is readyfor use.

In the drawings, FIGURE 1 is a partial cross-section of a syringe andvial united in the manner described.

FIGURE 2 shows an enlarged cross-section of the penetrable plug forreceiving the syringe and sealing the vial contents from the atmosphere.

FIGURE 3 illustrates a cross-section of the pop-off cannula cap.

Referring more specifically to the drawings, it will be seen from FIGURE1 that the syringe S has a cylindrical barrel 1 which is removablymounted atop vial 2. Barrel 1 terminates at its upper end in afinger-engageable collar 3 and at its lower end in boss 4, which is ofreduced diameter. Penetrable plug 5, which is secured in neck 6 of vial2, has a flange 18 engaged with the upper, flanged edge of the neck 6.Said plug 5 also has an upwardly opening bore 21 into which the boss 4of barrel 1 is received, thereby lending rigidity to the assembly andsealing the interior of vial 2 against the atmosphere. Overseal 7provides tamper-proof protection for plug 5 and clamps the flange 18against the neck 6 to improve the seal. Plunger 8 with thumb-engageableflange 9 is slidably mounted in barrel 1. One end of the plunger extendsbeyond the barrel 1 and the other end is connected to the piston 10,which is disposed in the barrel 1. Annular grooves 11 in piston -10provide annular ridges for slidable and sealing engagement with theinterior surface of barrel 1. Cannula 12, which is rigidly mounted inboss 4, communicates with the chamber 1A and extends through the plug 5into vial 2. Pop-ofi cap 13 is frictionally engaged over the free end ofcannula 12, whereby depression of plunger 8 develops pressure withinchamber 1A suflicient to dislodge cap 13 from the cannula 12 and causeit to fall freely into vial 2. Thereupon fluid 14 in chamber 1A can beforced into vial 2 for admixture with medicament 15 therein by downwardmovement of the plunger 8.

Where it is desired to reduce the overall height or the package, plunger8 can be provided with a threaded stem 16 of reduced diameter forthreadable engagement with a threaded receiver portion 17 of piston -10.

Plug 5 must not only provide an effective seal against contamination ofthe contents 15 of vial 2, but must also aflord substantially rigidsupport to the syringe mounted therein. FIGURE 2 shows more clearly afavored form of plug 5. Upper flange 18 of plug 5 has a diameter largerthan the internal diameter of neck 6 of vial 2. Body section 19 of plug5 is substantially the same diameter as the internal diameter of neck 6and has at least one ring 20 or annular ridge intermediate its length toafford a positive seal against said neck 6. The plug 5 has a centralbore 21 which extends downwardly into body section 19 intermediate itsdepth, said bore being of substantially the same diameter as boss 4. Atleast one circumferential ridge 22 extends into bore 21 from bodysection 19. The lower extremity of body section 19 presents a concavesurface 23, which provides a low point for complete withdrawal ofcontents from the inverted vial after mixture of ingredients.

Pop-off cap 13 is more clearly illustrated in FIGURE 3. Referencethereto shows a generally cylindrical and cup-shaped body having adownwardly extending channel 24 of substantially the external diameterof cannula 12. Channel 24 terminates at its lower end in an enlargedcavity 25 for receiving the tip of cannula 12 without contact therewith.Intermediate the length of channel 24 is at least one annular recess 26to facilitate presentation of a resilient and adhering surface tocannula 12. Cap 13 remains in place until downward movement of plunger 8develops sufiicient pressure in cavity 25 to expel said cap 13 fromcannula 12.

All parts in contact with medicament, with the excep tion of plug 5,piston 10 and pop-ofl? cap 13, cas "be made of glass, plastic or othersuitable material that can be sterilized. Plug 5, piston 10 and pop-offcap 13 are fabricated from materials such as high quality rubber orQsimilar materials can be suitably employed.

A particularly desirable feature of the present device is the ease withwhich it can be filled under aseptic conditions. With all parts andingredients rendered sterile, the solid or liquid medicament 15 ischarged to vial 2. Cannula 12 is inserted through overseal 7 and plug 5,and boss 4 positioned in bore 21. Cap 13 is applied over the tip ofcannula 12, the liquid diluent or medicament 14 is charged to barrel 1,and plunger 8 with piston 10 is inserted in barrel 1. Plug 5 with thesyringe unit in place is then inserted in neck '6 of vial 2 and theoverseal 7 applied to complete the assembly. It is apparent that othersequences can be employed, but the important aspect to be noted is thefreedom from diflicult assembly problems encountered here which commendsthis device to conventional manufacturing techniques.

What is claimed is:

1. A device for both maintaining separately and thereafter mixingsterile ingredients and for injecting the mixture, comprising incombination:

vial means having a neck communicating with a mixing chamber forcontaining a sterile first ingredient; penetra'ble plug means sealinglyinserted in the neck of said vial means; syringe means having a storagechamber for containing a sterile fluid inpredient, said syringe meanshaving plunger means in said storage chamber and having a cannulamounted thereon with a tip portion penetrating said plug means andextending into said mixing chamber;

holding means integral with said plug means and on said syringe meansadjacent said cannula releasably connecting and firmly holding saidsyringe means with respect to said vial means; and

cap means surrounding the inner end of said cannula,

said cap means having means frictionally engaging said cannula, said capmeans being spaced both from said tip portion of said cannula and fromsaid vial, said cap means being dislodged from said cannula by thepressure developed in said syringe upon movement of the plunger meanstoward the cannula while said holding means are connected, whereby saidfluid ingredient can be discharged into said vial means and mixed withsaid first ingredient, and the resulting fluent mixture can be withdrawnfrom said vial means into said syringe means .after which said holdingmeans are released so that said syringe means can be used to inject saidmixture.

2. A device according to claim 1 wherein the length of said cap means isless than the distance between the tip of the cannula and the wall ofthe vial toward whieb said cannula extends, when said holding means arec%* nected.

3. In combination:

(1) A mixing chamber for containing a first sterile ingredient forinjection and having an open end;

(2) A storage chamber for containing a sterile fluid ingredient forinjection afiixed to said mixing chamber;

(3) Penetrable plug means mixing chamber;

(4) A cannula extending from one end of said storage chamber throughsaid plug into said mixing cham-' ber and communicating therebetween;

(5) A plunger mounting a piston at its lower end slidable in saidstorage chamber, and

sealing the open end of said (6) A sealing cap having a generallycylindrical body of resilient material nonsticking with respect to thecannula surface, said body having a channel of substantially theexternal diameter of said cannula extending downwardly from the uppersurface of said body and terminating in an enlarged cavity for receivingthe tip of said cannula, but without contact therewith, said channelhaving at least one annular recess intermediate the length of saidchannel, whereby the cap will be frictionally retained over the tip ofthe cannula until pressure in the cavity,

developed by downward movement of the plunger and piston, is sufficientto overcome the adhering tendency of said cap and expel it freely intothe mixing chamber, thereby causing mixture in said mixing chamber ofsaid first ingredient and said fluid ingredient, whereupon the resultingfluid mixture can be withdrawn from said mixing chamber into saidstorage chamber and said storage chamber separated from said mixingchamber for use.

7 References Cited UNITED STATES PATENTS 2,289,677 7/1942 Perelson215-47 2,400,722 5/1946 Swan 2l547 X 2,591,046 4/1952 Brown 1282l82,666,434 1/1954 Ogle 1282.18 2,869,543 1/1959 Ratcliif et al 1. 1282182,959,170 11/1960 Laub 128-218 FOREIGN PATENTS 64,037 5/ 1955 France.806,736 10/ 1936 France. 1,063,341 8/ 1959 Germany.

DALTON L. TRULUCK, Examiner.

RICHARD A. GAUDET, Primary Examiner.

1. A DEVICE FOR BOTH MAINTAINING SEPARATELY AND THEREAFTER MIXINGSTERILE INGREDIENTS AND FOR INJECTING THE MIXTURE, COMPRISING INCOMBINATION: VIAL MEANS HAVING A NECK COMMUNICATING WITH A MIXINGCHAMBER FOR CONTAINING A STERILE FIRST INGREDIENT; PENETRABLE PLUG MEANSSEALINGLY INSERTED IN THE NECK OF SAID VIAL MEANS; SYRINGE MEANS HAVINGA STORAGE CHAMBER FOR CONTAINING A STERILE FLUID INPREDIENT, SAIDSYRINGE MEANS HAVING PLUNGER MEANS IN SAID STORAGE CHAMBER AND HAVING ACANNULA MOUNTED THEREON WITH A TIP PORTION PENETRATING SAID PLUG MEANSAND EXTENDING INTO SAID MIXING CHAMBER; HOLDING MEANS INTEGRAL WITH SAIDPLUG MEANS AND ON SAID SYRINGE MEANS ADJACENT SAID CANNULA RELEASABLYCONNECTING AND FIRMLY HOLDING SAID SYRINGE MEANS WITH RESPECT TO SAIDVIAL MEANS; AND CAP MEANS SURROUNDING THE INNER END OF SAID CANNULA,SAID CAP MEANS HAVING MEANS FRICTIONALLY ENGAGING SAID CANNULA, SAID CAPMEANS BEING SPACED BOTH FROM SAID TIP PORTION OF SAID CANNULA AND FROMSAID VIAL, SAID CAP MEANS BEING DISLODGED FROM SAID CANNULA BY THEPRESSURE DEVELOPED IN SAID SYRINGE UPON MOVEMENT OF THE PLUNGER MEANSTOWARD THE CANNULA WHILE SAID HOLDING MEANS ARE CONNECTED, WHEREBY SAIDFLUID INGREDIENT CAN BE DISCHARGED INTO SAID VIAL MEANS AND MIXED WITHSAID FIRST INGREDIENT, AND THE RESULTING FLUENT MIXTURE CAN BE WITHDRAWNFROM SAID VIAL MEANS INTO SAID SYRINGE MEANS AFTER WHICH SAID HOLDINGMEANS ARE RELEASED SO THAT SAID SYRINGE MEANS CAN BE USED TO INJECT SAIDMIXTURE.